If you weren’t aware last week, Rosglitazone or Avandia as it is known in the trade, was in front of the Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee at the FDA to see if it should remain on the market.

Overall the panel voted 20-12 to keep it on the market. That means 1/3rd of the panel wanted the drug removed from sale as they considered the harms so bad they outweigh any potential benefits. 17 of the panellists in favour wanted either tighter prescribing restrictions or more warnings about cardiovascular risks. Based on the evidence I'd have voted for its removal.

This is where it gets bad. Endocrinologist David Capuzzi, who was on the panel confirmed he has been a Glaxo's speakers for several years. Get this ‘he doesn't see the relationship as a conflict,’ of course not. Capuzzi defended the drug during the meeting. Oh, by the way he was one of three members who wanted the drug to remain on the market with no additional earnings or restrictions.

Dr Capuzzi received $3,750 from GSK between April 2009 and March 2010. He has also received $8,000 in speaking fees form GSK before that period and $3,000 in the 2nd quarter of this year, total $14,750.
One member who voted to keep Avandia on the market, Arthur Moss , said "I'm surprised we weren't told.” Do you know what, I’m not surprised, are you? It seems the information was never given to the committee or to the public, and the FDA is investigating.

Because they didn’t get 32 individuals without conflicts they should hold the panel meeting and vote again. Outrageous!

We first criticized this drug in 2006, when in the BMJ we first mooted rosiglitazone in the DREAM trial – which cost $23million - caused a significant increase in heart failure, despite the population being at low risk of such a problem. The drug showed no clear benefit at 3 years on clinical outcomes and the rate of all cardiovascular events tended to be higher in the treatment group.